Regional Pharmacovigilance Center, Department of Pharmacology, Pitié-Salpêtrière Hospital, Paris, France.
Brain Liver Pitié-Salpêtrière (BLIPS) Study Group, Assistance Publique-Hôpitaux de Paris, Groupement Hospitalier Pitié-Salpêtrière-Charles Foix, Département de Neurologie, Unité de réanimation neurologique, Sorbonne Université, Paris, France.
Br J Clin Pharmacol. 2019 Nov;85(11):2540-2546. doi: 10.1111/bcp.14073. Epub 2019 Aug 1.
Drug-induced aseptic meningitis (DIAM) is an adverse drug reaction of exclusion; only few studies have addressed this iatrogenic disease. The aim was to characterize DIAM and to identify suspected drugs.
Data were collected from the analysis of the French Pharmacovigilance Database from inception (1 January 1985) to 8 March 2017. All cases were initially analysed according to the French imputability method by institutional pharmacologists (clinicians or pharmacists). Further analyses of well documented cases were then performed.
In this study, 329 cases of aseptic meningitis were retrieved from the French Pharmacovigilance Database for a total of 429 suspected drugs. Analysis of 203 well documented cases, including 282 drugs, showed that the main reported classes were intravenous polyvalent immunoglobulin, nonsteroidal anti-inflammatory drugs (NSAIDs), vaccines, antimicrobials, intrathecal antimetabolites, corticosteroids and antalgics/anaesthetics (except NSAIDs). Lymphocytic (33.0%) and purulent (44.8%) meningitis represented the majority of cases of aseptic meningitis. In other cases, the cerebrospinal fluid was mixed (45-55% of neutrophils +45-55% of lymphocytes) or data about cerebrospinal fluid composition were lacking. Most DIAM cases (96%) had a favourable reported outcome with full recovery or minimal residual symptoms.
The most frequently involved drugs in DIAM were intravenous polyvalent immunoglobulin, NSAIDs, vaccines, and antimicrobials and this without being able to differentiate them in terms of biological characteristics. Although further studies are needed to better understand the pathophysiological mechanisms of DIAM, a continuous enrichment of pharmacovigilance databases is essential to identify new signals and to help clinicians in the understanding of DIAM.
药物诱导的无菌性脑膜炎(DIAM)是一种排他性的药物不良反应;仅有少数研究涉及这种医源性疾病。本研究旨在对 DIAM 进行特征描述并确定可疑药物。
本研究从法国药物警戒数据库中收集了自 1985 年 1 月 1 日至 2017 年 3 月 8 日的数据。所有病例最初均由机构药剂师(临床医生或药剂师)根据法国归因方法进行分析。随后对记录良好的病例进行了进一步分析。
本研究从法国药物警戒数据库中检索到 329 例无菌性脑膜炎病例,共涉及 429 种可疑药物。对 203 例记录良好的病例进行分析,包括 282 种药物,结果显示,主要报告的类别为静脉用多价免疫球蛋白、非甾体抗炎药(NSAIDs)、疫苗、抗菌药物、鞘内抗代谢物、皮质类固醇和镇痛药/麻醉剂(除外 NSAIDs)。淋巴细胞性(33.0%)和化脓性(44.8%)脑膜炎是无菌性脑膜炎的主要类型。在其他情况下,脑脊液为混合性(45-55%的中性粒细胞+45-55%的淋巴细胞)或缺乏脑脊液成分数据。大多数 DIAM 病例(96%)的预后良好,完全恢复或仅有轻微残留症状。
DIAM 最常涉及的药物为静脉用多价免疫球蛋白、NSAIDs、疫苗和抗菌药物,但无法根据生物学特征对它们进行区分。尽管需要进一步研究以更好地理解 DIAM 的病理生理机制,但不断丰富药物警戒数据库对于识别新信号和帮助临床医生理解 DIAM 至关重要。